AZD5985 Single Ascending Dose Study
- Registration Number
- NCT00967356
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
- Provision of signed, written and dated informed consent prior to any study specific procedure
- Healthy male subjects aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start
Exclusion Criteria
- History or presence of any clinically significant disease or disorder in the opinion of the investigator
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
- Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A AZD5985 AZD5985 B Placebo Placebo
- Primary Outcome Measures
Name Time Method Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) Frequent sampling occasions during study days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables Frequent sampling occasions during study days
Trial Locations
- Locations (1)
Research Site
πΈπͺGoteborg, Sweden